Trial · NCT03419364
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Mean Arterial Blood Pressure (MAP) | Baseline, 48 hours | Blood pressure (mmHg) will be used to observe the effect of nicotinamide. The highest MAP (defined as the highest MAP within the 24 hour period prior to the administration of study agent) and the highest MAP through 24 hours after study drug administration. |
| Secondary | Number of Participants With Alanine Aminotransferase (ALT) =/> 3x Upper Limit of Normal (ULN) | Within 24 hours of any dose, up to a maximum 4 weeks | |
| Secondary | Number of Participants With Aspartate Aminotransferase (AST) =/> 3x Upper Limit of Normal (ULN) | Within 24 hours of any dose, up to a maximum 4 weeks | |
| Secondary | Number of Participants With Maternal Side Effects | From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks | Maternal side effects are defined as: facial erythema, hives, sore mouth, dry hair, fatigue, flushing, headache, nausea, and heart burn. |
| Secondary | Percentage of Women Maternal Abdominal Tenderness | From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks | |
| Secondary | Percentage of Women With Headache Unrelieved by Oral Analgesics | From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks | |
| Secondary | Percentage of Women With Hematocrit Decrease of More Than 3% | From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks | |
| Secondary | Percentage of Women With Less Than 500 cc Urine Output in 24 Hours | From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks | |
| Secondary | Percentage of Fetuses With Category III Non Stress Test Results | From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks | A Non Stress Test is a determination of the current well-being of the fetus, as measured by the fetal heart rate. Category I indicates that the fetus is in a state of well-being and is tolerating the intrauterine environment. Category II indicates a fetal heart rate that is showing some signs of distress. In this instance, obstetric providers will try to improve the intrauterine environment to allow the pregnancy to continue. Category III relates to a fetus whose well-being is compromised - usually requiring rapid intervention, ie expedient delivery. |
| Secondary | Percentage of Fetuses With Biophysical Profile < 6 | From initial administration of study agent until 24 hours post last dose | |
| Secondary | Mean Peak Nicotinamide Level | at 1 hour post 1000 mg nicotinamide administration on Day 1 | The mean was calculated for each group using blood samples drawn on Day 1 at 1 hour post 1000 mg nicotinamide administration routinely given at 8 a.m. Peak nicotinamide level expected at 1 hour post dose. |
| Secondary | Mean Trough Concentration Nicotinamide Administration | 8 hours after the 8 a.m. 1000 mg nicotimamide administration on Day 1 | The mean was calculated for each group for blood samples drawn on Day 1 8 hours post 1000 mg nicotinamide administration routinely given at 8 a.m. Trough nicotinamide level is measured immediately prior to the next dose. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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GET https://conductscience.org/api/trials/v1/NCT03419364/registered